Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant's election with traverse of species A-6 (a system as shown and described in fig. 6) in the reply filed on 10/27/2025 is acknowledged. The traversal is on the ground(s) that
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This is not found persuasive because each disclosed species (species of fig. 1 through fig. 6) are different embodiments of a system having patentably distinct set of elements within apparatus that requires separate search. For example, species of figure 1 discloses a system comprising processing vessels 12 (such as activated carbon) and 14 for purification of water, and a plurality of sensors 13. System of fig. 1 do not require concentrate sources or mixing of concentrate that would require a search that is different than a search that requires source of concentrates, mixing of concentrate, providing bypass/returning conduits, etc. Species of fig. 2 discloses a system that is distinct from fig. 1 because it comprises specific type of purification devices (such as micron filter, RO, UV, and ultrafilter) that are not present in system of claim 1 which would require a different search. Species of fig. 3 includes a dialysis fluid preparation system 34 in combination with a container 36 and a filter 38. Species of fig. 1 and 2 do not disclose a dialysis fluid preparation component. Species of fig. 4 discloses treatment of spent dialysate that is not disclosed in species of fig. 3. Species of fig. 5 discloses a specific type dialysis system, i.e. hemodialysis system, and species of fig. 6 discloses a system for preparation of dialysis solution comprising concentrate source, a heater, purification devices, pumps, valves, sensors, filter and a recirculation/return conduit. Each of the discloses species comprises different combinations of devices that would require different search.
The requirement is still deemed proper and is therefore made FINAL.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21, 29 of U.S. Patent No. 11400193. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 21 of US’193 recites additional features such as a second concentrate pump, the sensor being MEMS sensor, determining pumping speed of the first and second pumps, and adjusting speed of the pumps. Limitations of claim 3 are present in claim 29 of US ‘193.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(e) the invention was described in a patent granted on an application for patent by another filed in the United States before the invention thereof by the applicant for patent, or on an international application by another who has fulfilled the requirements of paragraphs (1), (2), and (4) of section 371(c) of this title before the invention thereof by the applicant for patent.
The changes made to 35 U.S.C. 102(e) by the American Inventors Protection Act of 1999 (AIPA) and the Intellectual Property and High Technology Technical Amendments Act of 2002 do not apply when the reference is a U.S. patent resulting directly or indirectly from an international application filed before November 29, 2000. Therefore, the prior art date of the reference is determined under 35 U.S.C. 102(e) prior to the amendment by the AIPA (pre-AIPA 35 U.S.C. 102(e)).
Claim(s) 1, 3, 5, and 6 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Babb et al. (US 4399036).
Regarding claim 1, Babb teaches a fluid preparation apparatus (the limitation “for a renal failure treatment” is intended use of the apparatus without imparting additional structure) comprising:
an inlet configured to receive water from a water source (refer water is provided through conduit 81);
a fluid line fluidly connected to the inlet (water source is connected to water line 81);
a concentrate pump fluidly connected to the fluid line at a mixing point, the concentrate pump configured to pump concentrate from a concentrate container to mix with the water beginning at the mixing point to form a fluid mixture (refer pump 22 is connected to concentrate container 34 supplying concentrate to a mixing tank where water is mixed with the concentrate);
a sensor located downstream from the mixing point and configured to measure a composition characteristic of the fluid mixture (Refer sensors 66, 68);
a valve (70) located downstream from the sensor; and
at least one controller (42) operably coupled to the concentrate pump, the valve, and the sensor, the at least one controller configured to receive at least one composition characteristic value from the sensor, and cause the valve to route the fluid mixture for the renal failure treatment when the at least one composition characteristic value indicates that the fluid mixture is suitable for the renal failure treatment (refer Column 6 – Lines 45-52 disclosing “By-pass valve 70 is positioned in conduit 62 downstream of probes 64, 66 and 68 and is operably associated with control module 42 so that any deviation from normal operating conditions or dialysate characteristics will cause by-pass valve 70 to be actuated so as to divert the dialysate stream passing through conduit 62 to drain via drain passageway 72 and to interrupt the dialysate flow to a dialysis cell”).
Regarding claim 3, Babb teaches limitations of claim 1 as set forth above. Babb teaches that the sensor (66) is a conductivity sensor (refer fig. 3).
Regarding claim 5, Babb teaches limitations of claim 1 as set forth above. Babb teaches providing water through conduit 81 for preparation of dialysate solution (refer fig. 3).
Regarding claim 6, Babb teaches limitations of claim 1 as set forth above. Babb teaches providing a mixing chamber (refer tank 26).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 2 and 10 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Babb et al. (US 4399036).
Regarding claim 2, Babb teaches limitations of claim 1 as set forth above. Babb discloses providing detecting/monitoring multiple parameters including pH, temperature, and conductivity. Therefore, selecting an ion- selective sensor suitable for sensing two or more of an ion selected from the group consisting of ammonium, sodium, calcium, magnesium, potassium, carbonate, bicarbonate, hydrogen or hydronium, hydroxyl, chloramine, and chloride would have been an obvious matter of choice to one of ordinary skill in the art.
Regarding claim 10, Babb teaches limitations of claim 1 as set forth above. Babb further discloses “Temperature-compensated conductivity probe 28 is provided associated with mixing tank 26 and controls operation of pump 22 to produce the diluted aqueous carbonate solution. Probe 28 provides an output signal that is received by pump control means 24 and regulates the rate of introduction of the concentrated carbonate solution into mixing tank 26. The purpose of this conductivity control loop is to maintain a substantially constant carbonate ion concentration in the diluted aqueous carbonate solution. Inasmuch as conductivity is a function of concentration as well as solution temperature, a temperature-compensated signal to pump control 24 is desirable” (refer column 5 -lines 10-22). Babb also discloses “The output signal from pH sensor 64 can be further utilized to control the operation of carbonate concentrate pump 22 alone or together with the output signal from conductivity and temperature probe 28, as desired.” (refer column 6 – lines 41-44). Therefore, controlling pumps to control concentration of carbonate/bicarbonate concentrate is taught/suggested by Babb. Applying same concept to control addition of acid concentrate would have been obvious to one of ordinary skill in the art based on the above cited disclosure of Babb.
Claim 4 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Babb et al. (US 4399036), in view of Kenley et al. (US 5591344).
Regarding claim 4, Babb teaches limitations of claim 1 as set forth above. Babb does not teach that the sensor is suitable for sensing chlorine and chloramine.
Kenley teaches a system for dialysis system and testing of chlorine and chloramine in water to ensure the water going to the machine does not contain any chlorine (Refer column 9 -lines 1-15, column 10-lines 49-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the system of Babb to include monitoring of chlorine and/or chloramine to ensure no chlorine is present in water while using the water for preparation of dialysate as taught by Kenley. Use of a sensor to automate chlorine detection would have been an obvious matter of choice to one of ordinary skill in the art.
Claim 11-13, 15-16 and 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Babb et al. (US 4399036), in view of Felding (US 2005/0040110 A1).
Regarding claim 1, Babb teaches a fluid preparation apparatus (the limitation “for a renal failure treatment” is intended use of the apparatus without imparting additional structure) comprising:
an inlet configured to receive water from a water source (refer water is provided through conduit 81);
a fluid line fluidly connected to the inlet (water source is connected to water line 81);
a concentrate pump fluidly connected to the fluid line at a mixing point, the concentrate pump configured to pump concentrate from a concentrate container to mix with the water beginning at the mixing point to form a fluid mixture (refer pump 22 is connected to concentrate container 34 supplying concentrate to a mixing tank where water is mixed with the concentrate);
a sensor located downstream from the mixing point and configured to measure a composition characteristic of the fluid mixture (Refer sensors 66, 68);
a valve (70) located downstream from the sensor; and
at least one controller (42) operably coupled to the concentrate pump, the valve, and the sensor, the at least one controller configured to receive at least one composition characteristic value from the sensor, and cause the valve to route the fluid mixture for the renal failure treatment when the at least one composition characteristic value indicates that the fluid mixture is suitable for the renal failure treatment (refer Column 6 – Lines 45-52 disclosing “By-pass valve 70 is positioned in conduit 62 downstream of probes 64, 66 and 68 and is operably associated with control module 42 so that any deviation from normal operating conditions or dialysate characteristics will cause by-pass valve 70 to be actuated so as to divert the dialysate stream passing through conduit 62 to drain via drain passageway 72 and to interrupt the dialysate flow to a dialysis cell”).
Babb does not teach that a purification cartridge comprising a purification medium is provided for water, and a heater for heating the water received from the purification cartridge.
Felding teaches a system for preparing dialysis fluid comprising a purification cartridge ( [0019] discloses RO filter and ultrafilter 11) comprising a purification medium (ultrafilter) for water; a heater (10) for heating the water received from the purification cartridge; a pump for (16, 22) for pumping and metering a concentrate (20, 15), a filter (48) for filtering the dialysis solution, a plurality of sensors (9, 19) for measuring quality of dialysis solution, and a controller (58) for monitoring and controlling components of the system.
It would have been obvious to one of ordinary skill in the art to modify the system of Babb to include filter cartridge to purify water prior to mixing with dialysate concentrates, a heater to heat the purified water, and a filter to purify prepared dialysate as taught by Felding.
Regarding claim 12, modified Babb teaches limitations of claim 11 as set forth above. Felding further teaches providing an ultrafilter (11). The limitation “for removing bacteria and microorganism” is intended use of the ultrafilter without imparting additional structure.
Regarding claim 13, modified Babb teaches limitations of claim 11 as set forth above. Felding further teaches an RO filter purifying water (refer [0019]).
Regarding claim 15, modified Babb teaches limitations of claim 11 as set forth above. Babb teaches providing an air trap (refer 59) for removing air from dialysate.
Regarding claim 16, modified Babb teaches limitations of claim 11 as set forth above. Babb teaches providing fresh water (through conduit 81). Felding also teaches providing fresh water (through 12).
Regarding claim 20, Babb teaches limitations of claim 1 as set forth above. Babb further discloses “Temperature-compensated conductivity probe 28 is provided associated with mixing tank 26 and controls operation of pump 22 to produce the diluted aqueous carbonate solution. Probe 28 provides an output signal that is received by pump control means 24 and regulates the rate of introduction of the concentrated carbonate solution into mixing tank 26. The purpose of this conductivity control loop is to maintain a substantially constant carbonate ion concentration in the diluted aqueous carbonate solution. Inasmuch as conductivity is a function of concentration as well as solution temperature, a temperature-compensated signal to pump control 24 is desirable” (refer column 5 -lines 10-22). Babb also discloses “The output signal from pH sensor 64 can be further utilized to control the operation of carbonate concentrate pump 22 alone or together with the output signal from conductivity and temperature probe 28, as desired.” (refer column 6 – lines 41-44). Therefore, controlling pumps to control concentration of carbonate/bicarbonate concentrate is taught/suggested by Babb. Applying same concept to control addition of acid concentrate would have been obvious to one of ordinary skill in the art based on the above cited disclosure of Babb.
Claim 14 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Babb et al. (US 4399036), in view of Felding (US 2005/0040110 A1) as applied to claim 11 above, and further in view of Burbank et al. (US 2009/0182263 A1).
Regarding claim 14, modified Babb teaches limitations of claim 11 as set forth above. Modified Babb does not teach that the system comprises an ultraviolet light source for irradiating the water or the fresh dialysis solution, the ultraviolet light source placed upstream of the filter.
Burbank teaches a system for preparation of purified water and medicaments for blood treatment (refer abstract), wherein a UV lamp providing sterilization mechanism and a mechanism for removing chlorine and chloramines from water (Refer [0092]). Burbank also teaches that the UV lamp is provided upstream of filter module (910).
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the system of modified Babb to include an ultraviolet light source for providing sterilization mechanism and a mechanism for removing chlorine and chloramines from water, wherein the UV light source is provided upstream of the filter module as taught by Burbank.
Allowable Subject Matter
Claims 7-9 and 17-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claims 7 and 17 require the systems of claim 1 and 11 to include “wherein the fluid line is a to-patient fluid line and the sensor is a first sensor, the apparatus further comprising: a patient outlet line positioned to receive used dialysate from a patient; and a second sensor provided in the patient outlet line to measure a composition characteristic of the used dialysate”. The above cited prior arts fail to teach or suggest the limitations of claims 7 and 17. Claims 8-9 are dependent of claim 7 and claims 18-19 are dependent of claim 17.
Conclusion
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/PRANAV N PATEL/Primary Examiner, Art Unit 1777